UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056044 |
|---|---|
| Receipt number | R000064047 |
| Scientific Title | Effectiveness of Bufei Formula and Bufei Yishen Formula as Adjuvant Treatment for Chronic Obstructive Pulmonary Disease |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2025/01/16 10:00:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effectiveness of Bufei Formula and Bufei Yishen Formula as Adjuvant Treatment for Chronic Obstructive Pulmonary Disease
Acronym
Effectiveness of Bufei Formula and Bufei Yishen Formula as Adjuvant Treatment for Chronic Obstructive Pulmonary Disease
Scientific Title
Effectiveness of Bufei Formula and Bufei Yishen Formula as Adjuvant Treatment for Chronic Obstructive Pulmonary Disease
Scientific Title:Acronym
Effectiveness of Bufei Formula and Bufei Yishen Formula as Adjuvant Treatment for Chronic Obstructive Pulmonary Disease
Region
| Japan | North America | South America |
| Australia | Europe | Africa |
Condition
Condition
COPD
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This meta-analysis aims to comprehensively analyze the effectiveness and safety of the Bufei formula.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was the annual exacerbation rate.
Key secondary outcomes
Secondary outcomes included the Modified British Medical Research Council (mMRC) dyspnea scale, 6-minute walk distance (6MWD), and forced expiratory volume in one second as a percentage of the predicted value (FEV1%).
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Studies were included if they met the following criteria: (1) Randomized controlled trials; (2) Patients treated with Bufei Formula or its modified versions; (3) Included relevant outcomes, such as exacerbation rates.
Key exclusion criteria
Studies were excluded if they: (1) Were not available in full text; (2) Were animal or cellular studies; (3) Involved patients without COPD; (4) Provided insufficient information or data.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yan |
| Middle name | |
| Last name | Zhao |
Organization
Saga University Hospital
Division name
Liver Center
Zip code
849-8501
Address
5-1-1 Nabeshima Saga, 849-8501, Japan
TEL
952-31-6511
23624015@edu.cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Yan |
| Middle name | |
| Last name | Zhao |
Organization
Saga University Hospital
Division name
Liver Center
Zip code
849-8501
Address
5-1-1 Nabeshima Saga, 849-8501, Japan
TEL
952-31-6511
Homepage URL
23624015@edu.cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University Hospital
Institute
Department
Personal name
Funding Source
Organization
Saga University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saga University Hospital IRB
Address
5-1-1 Nabeshima Saga, 849-8501, Japan
Tel
952-31-6511
23624015@edu.cc.saga-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
775
Results
Bufei and Bufei Yishen formulas are effective adjuvant treatments for COPD
Results date posted
| 2025 | Year | 01 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064047
